UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The characteristic of arch height and influence of dynamic balance by intervention of exercise in flatfoot.
Title of the study (Brief title)	The characteristic of arch height and influence by intervention of exercise in flatfoot.
Region	Japan

Condition
Condition	flatfoot
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. The investigation of characteristic of arch height in ages and habit of exercise. 2. The investigation of persistent effect after the intervention by short foot exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1.Questionnaire:name,gender,age,dominant side,history of exercise,medical history 2.Height 3.Weight 4.Foot shape 5.Center of pressure in testing Y-Balance Test(Before intervention and after four weeks)
Key secondary outcomes	None

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Measurement periods set of this research are 3 times, and is total of 6 weeks. Short foot exercise is guided in the 1st time of measurement for classified flat foot group. Short foot exercise is the movement that the contraction of foot intrinsic muscle which shortens foot assembly. The movement maintain for 10 seconds, take a rest for 5 seconds and repeat in 30 minutes. Doing this exercise 3 times a week until the 2nd time of measurement for 4 weeks. The 3rd time will be measured 2 weeks later. Make sure that flat foot group won't do Short foot exercise after the 2nd time of measurement until the 3rd time of measurement.
Interventions/Control_2	Measurement periods set of this research are 3 times, and is total of 6 weeks. No intervention is guided in the 1st time of measurement for control group.The 2nd time of measurement will be measured 4 weeks later.The 3rd time will be measured 2 weeks later of The 2nd time of measurement.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Can stand independently. 2.No history of fructure in lower extremity. 3.No sport training in lower extremity. 4.No systemic disease.
Key exclusion criteria	When the person in charge or the object judges that couldn't continue the measurment, the measurment is stopped immediately.
Target sample size	30

Research contact person
Name of lead principal investigator	KUO SHU HAN
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima Tokorozawa Saitama 359-1192 Japan
TEL	070-2178-3657
Email	shokan0714@hotmail.com

Public contact
Name of contact person	KUO SHU HAN
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima Tokorozawa Saitama 359-1192 Japan
TEL	070-2178-3657
Homepage URL
Email	shokan0714@hotmail.com

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 30 Day
Anticipated trial start date	2018 Year 04 Month 30 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The relationship between arch height index and age is increasing before age of 40, and starts to decline from age of 40, and the relationship between arch height index and BMI is declined in excess weight. The arch height index in male was higher than in females. The trail of COP in the ML direction of flatfoot was narrower than that of neutral foot.The intervention of SFE for four weeks could effectively improve the arch height and maintain the height for at least three weeks.
Other related information

Management information
Registered date	2018 Year 04 Month 20 Day
Last modified on	2019 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036642